Comparison of aripiprazole and risperidone effectiveness in first episode non-affective psychosis: Rationale and design of a prospective, randomized, 3-phase, investigator-initiated study (PAFIP-3)
-
Mayoral-van Son J [1] ; Marcos Gómez-Revuelta [2] ; Rosa Ayesa-Arriola [2] ; Javier Vázquez-Bourgón [2] ; Víctor Ortiz-García de la Foz [2] ; Miguel Ruiz-Veguilla [1] ; Nathalia Garrido [1] ; Diana Tordesillas-Gutiérrez [2] ; Esther Setién-Suero [2] ; Benedicto Crespo-Facorro [1]
-
[1] Hospital Universitario Virgen del Rocío
Hospital Universitario Virgen del Rocío
Sevilla, España
-
[2] Hospital Universitario Marqués de Valdecilla
Hospital Universitario Marqués de Valdecilla
Santander, España
-
- Localización: Revista de psiquiatría y salud mental, ISSN 1888-9891, ISSN-e 1989-4600, Vol. 14, Nº. 3, 2021, págs. 157-163
- Idioma: inglés
- Texto completo no disponible (Saber más ...)
-
Resumen
Background Selecting the most effective treatment represents a critical challenge with the potential of modifying the long-term prognosis of individuals suffering a first break of psychosis. Head-to-head clinical trials comparing effectiveness among antipsychotic drugs in individuals with a first-episode of non-affective psychosis (FEP) are scarce.
Methods The rationale and design of a 3 phases clinical trial (PAFIP-3, NCT02305823) comparing the effectiveness of aripiprazole and risperidone, and to additionally assess the benefits of an early use of clozapine in primary treatment-resistant patients is reported. The design encompasses of 5 work packages (medication algorithm, cognitive functioning, psychoeducation/vocational functioning, imaging and biological markers) addressing critical issues and needs of first episode psychosis individuals and their cares. The primary outcome measure was treatment effectiveness assessed by all-cause treatment discontinuation rate.
Results 266 individuals have been included in the randomization study phase I (risperidone vs. aripiprazole). At 3 months, the retention rate was of 94% (249/266), 48(19.3%) patients have gone through phase II (olanzapine treatment), and 7(2.8%) entered the clozapine phase (phase III).
Discussion The PAFIP 3 clinical trial may provide relevant information about clinical guidelines to optimally treat patients with a first episode of non-affective psychosis and the benefits and risks of an early use of clozapine in treatment resistant patients.
